Biometrics and data management are closely linked, both pursuing the same objective, namely high-quality data.
Using appropriate statistical methods biometrics processes study results and draws conclusions with regard to the predefined study objectives. Therefore, it is advisable to seek statistical advice already at the earliest stage of a clinical trial.
Our experts will be glad to take over the following services for you:
- Providing statistical input for the study protocol
- Statistical consulting and support in the selection of clear study objectives
- Development of the “Statistical Analysis Plan” (SAP)
- Sample size estimation, power analyses
- Randomisation and preparation of emergency envelopes
- Biometrical data analysis (validated according to FDA 21 CFR Part 11)
- Data preparation and data cleaning
- Post hoc analysis
- Consultant activity
- Preparation of a final report, either according to ICH or individually according to your specifications